GMP Plasmid Manufacturing Services
Integrated Plasmid Production to Streamline and Accelerate Viral Vector Manufacturing
With over 20 years of experience in cell and gene therapy manufacturing, Andelyn understands how plasmid DNA manufacturing impacts viral vector packaging performance. Our integrated plasmid manufacturing approach creates a seamless transition from plasmid production through vector development to GMP manufacturing with dedicated program management throughout.
Under one MSA, our integrated approach streamlines the path from plasmid production through vector development to commercial manufacturing, with integrated program management for both plasmid and vector programs provided by an experienced plasmid manufacturer and plasmid company.
A Commitment to Quality at Every Stage of Your Program
Andelyn offers a spectrum of plasmid DNA grades tailored to support your project at every stage. Our unique approach to quality control is built on a single-use mindset, and we manufacture all GMP plasmid DNA products in a cleanroom environment.
We prioritize high-quality plasmid DNA to ensure consistency and compliance with clinical development and GMP manufacturing standards.
As one of the experienced plasmid manufacturing companies, we provide traceability from raw materials through release, aligning with regulatory expectations for DNA plasmid manufacturing and consistent plasmid production services.
| Research | Tox | GMP | |
|---|---|---|---|
| Applications | In vitro R&D, PC studies | Toxicology studies | Clinical, Commercial |
| Scale | Flask | Flask / 50L Fermenter | Flask / 50L Fermenter |
| Testing Panel | Reduced | Extended | Extended |
| Cloning |  | | |
| Yield Assessment / DOE | | | |
| CoA | | | |
| E. coli MCB Production | | | |
| Plasmid Stability (Upon Request) | | | |
| Single-use disposable | | | |
| TSE/BSE statement | | | |
| Manufactured in clean room | | ||
| QA oversight | |
Customized Testing Strategy to Meet Specific Program Requirements
| Source | Research | Tox | GMP | |
|---|---|---|---|---|
| DNA Homogeneity | In-house | | | |
| Identity | In-house | | | |
| Purity | In-house | | | |
| Restriction Digest | In-house | | | |
| Concentration | In-house | | | |
| Identity (DNA) | In-house / NCH IGM | | | |
| Endotoxin | In-house | | | |
| Residual Host Protein | In-house | | ||
| Residual Host Genomic DNA | In-house | | ||
| Residual Host RNA | In-house | | ||
| pH | In-house | | ||
| Mycoplasma | In-house | |
Andelyn Development Center
Explore the Andelyn Development Center (ADC), where precision-based process development, preclinical manufacturing, and analytical capabilities converge for plasmids and viral vectors. As the cornerstone of our experience in gene and cell therapy, the ADC supports plasmid manufacturing, plasmid production service optimization, and analytical method development, ensuring fit-for-purpose solutions from early discovery to IND-enabling studies.
Andelyn Commercial Center
Step inside the Andelyn Commercial Center (ACC), our clinical and commercial production facility built for the rigors of cell and gene therapy manufacturing. With advanced cleanroom technologies and GMP-compliant design and operations, the ACC produces GMP and commercial-grade, high-quality plasmids and viral vectors. This facility anchors our plasmid suppliers capabilities and enables our plasmid CDMO to reliably advance programs to market while maintaining robust controls required for GMP plasmid DNA and compliant plasmid manufacturing.
In-House Plasmid Production Means Secure Supply Chains
Working closely with a CDMO that performs in-house plasmid production affords companies the opportunity to collaborate, optimize processes, and create efficiencies.
As a full-service plasmid manufacturer and plasmid DNA manufacturer, we provide continuity and risk mitigation by integrating plasmid manufacturing with downstream workflows.